JMSOLUTION MARINE LUMINOUS PEARL SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream

JMSOLUTION MARINE LUMINOUS PEARL SUNSCREEN by

Drug Labeling and Warnings

JMSOLUTION MARINE LUMINOUS PEARL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by GPNY CORP, Rebom Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 2.7 %
Homosalate 9.8 %
Octisalate 4.7 %
Octocrylene 9.7 %

Purpose

sunscreen

Uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged skin or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ apply liberally 15 minutes before sun exposure.
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
■ children under 6 months of age: Ask a doctor
■ reapply at least every 2 hours
■ use a water-resistant sunscreen if swimming or sweating

Other information

■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Water, Butyloctyl Salicylate, Niacinamide, Polysorbate 80, Dipropylene Glycol, Benzyl Glycol, Sea Water, Glycerin, Glyceryl Stearate SE, Polymethylsilsesquioxane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Poly C10-30 Alkyl Acrylate, Butylene Glycol, Arginine, Ethylhexylglycerin, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Adenosine, Ethyl Hexanediol, Caulerpa Lentillifera Extract, Tocopheryl Acetate, 1,2-Hexanediol, Laminaria Japonica Extract, Pearl Extract, Pentylene Glycol, Hizikia Fusiforme Extract, Caprylyl Glycol, Ulva Australis Extract, Spirulina Maxima Extract, Hydrolyzed Collagen, Ecklonia Cava Extract, Undaria Pinnatifida Extract, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Hyaluronic Acid, Potassium Hyaluronate, Sodium Guaiazulene Sulfonate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Raspberry Ketone, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate, Copper Tripeptide-1, sh-Decapeptide-7, sh-Octapeptide-4, sh-Oligopeptide-9, sh-Pentapeptide-19, Fragrance, Linalool, Citronellol, Limonene

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JMSOLUTION MARINE LUMINOUS PEARL SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84754-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.9 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.85 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.35 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.35 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHOHEXADIOL (UNII: M9JGK7U88V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEA (UNII: W4X7H8GYFM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
BENZYL GLYCOL (UNII: 06S8147L47)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
ARGININE (UNII: 94ZLA3W45F)
XANTHAN GUM (UNII: TTV12P4NEE)
CAULERPA LENTILLIFERA EXTRACT (UNII: VJ0188QOU3)
LAMINARIA JAPONICA EXTRACT (UNII: WE98HW412B)
ULVA AUSTRALIS (UNII: 2XBS658AKF)
ECKLONIA CAVA (UNII: UXX2N5V39P)
DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE)
SODIUM GUALENATE (UNII: 19WSH095WP)
RASPBERRY KETONE (UNII: 7QY1MH15BG)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
SARGASSUM FUSIFORME EXTRACT (UNII: X436TJ4A11)
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84754-052-02	1 in 1 BOX	11/07/2024
1	NDC: 84754-052-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/07/2024

Labeler - GPNY CORP (108497367)

Establishment
Name	Address	ID/FEI	Business Operations
Rebom Co., Ltd.		695951708	manufacture(84754-052)